LIGAMAX EL5MLRecalls & reported problems
Ethicon Endo-Surgery, LLC · Ligamax 5 mm Endoscopic Multiple Clip Applier · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Ethicon Ligamax clip applier is a surgical tool that places clips during keyhole surgery. Many reports describe clips that do not form properly, fail to fire, or jam inside the tool. Some reports say another device was used to finish the procedure. The 3,755 reports include 3 deaths and 79 injuries. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 3,808
- Deaths reported
- 3
- Injuries reported
- 79
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3,808 adverse event reports that list this exact device (DI 10705036001843), received between May 26, 2017 and Sep 30, 2026 — classified as 3 deaths, 79 injuries, 3,726 malfunctions.
The most frequently reported specific device problem is “Failure to Form Staple” (1,982 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Form Staple1,982
- Failure to Fire913
- Mechanical Problem301
- Mechanical Jam280
- Difficult to Open or Close173
- Firing Problem141
- Insufficient Device Problem Information132
- Misfire60
Patient problems
- No Clinical Signs, Symptoms or Conditions2,407
- No Consequences Or Impact To Patient1,335
- Hemorrhage/Blood Loss/Bleeding50
- Failure to Anastomose34
- No Code Available21
- Insufficient Information11
- Blood Loss8
- Pain6
Recent adverse event reports
The 25 most recent of 3,808 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanics Altered
It was reported that during an Unknown procedure the device did not function properly and cut the suture threads.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946597 ↗MalfunctionSep 30, 2026Mechanics Altered
It was reported that during an Unknown procedure the device did not function properly and cut the suture threads.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946595 ↗MalfunctionSep 29, 2026Failure to Fire
It was reported that during an Unknown procedure a device misfired but they were able to get that one to fire and use. There are Injuries or Adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935706 ↗MalfunctionSep 29, 2026Failure to Form Staple
It was reported that during a cholecystectomy procedure, 5 mm automatic clip appliers were requested. The complete device was provided. During the procedure, when the physician attempted to use the Ligamax, he reported that the clips being deployed were not closing tightly enough. Calmly, he requested another device of the same type. The issue was reported to the manager, and a replacement unit was provided. The replacement functioned correctly.The surgery was completed without any complications or delays.Was any patient or user harm reported? No
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931592 ↗MalfunctionSep 28, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921496 ↗MalfunctionSep 25, 2026Failure to Fire
It was reported that during an Unknown procedure the clip applier "jammed" during lap chole procedure. There was no patient consequence reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50896058 ↗MalfunctionSep 24, 2026Mechanical Jam
It was reported that, during a thoracoscopic right lung partial resection, the clip could not be loaded into an applier properly and something was caught. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884213 ↗MalfunctionSep 24, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883875 ↗MalfunctionSep 24, 2026Failure to Fire; Mechanical Jam
It was reported that during an unknown surgery. The surgeon noted that the applier could not work properly, and the rotary knob is difficult to turn Changed the new one to complete surgery. There was no patient consequence reported. No additional information can be provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883757 ↗MalfunctionSep 24, 2026Failure to Fire
It was reported that during an unknown procedure there was an issue with the device.There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883707 ↗MalfunctionSep 24, 2026Failure to Fire
It was reported that during an unknown procedure there was an issue with the device.There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883702 ↗MalfunctionSep 24, 2026Failure to Fire
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883689 ↗MalfunctionSep 24, 2026Failure to Fire
It was reported that during an unknown procedure there was an issue with the device.There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883686 ↗MalfunctionSep 22, 2026Mechanical Problem
It was reported that during an Unknown procedure the tip of clip applier broke as being used.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50857125 ↗MalfunctionSep 22, 2026Failure to Fire
It was reported that during an unknown procedure there was an issue with the device. There was no patient harm.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50854994 ↗MalfunctionSep 22, 2026Failure to Fire
It was reported that during an unknown procedure the clip is stuck, unable to fire the clip. Have there been reports of injuries from patients or users? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853067 ↗MalfunctionSep 22, 2026Failure to Fire
It was reported that during an Unknown procedure the clip is stuck.Have there been reports of injuries from patients or users? No.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50853024 ↗MalfunctionSep 22, 2026Failure to Fire; Component or Accessory Incompatibility
It was reported that during an Unknown procedure the device does not work. Does not fit into the 5mm trocar.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852973 ↗MalfunctionSep 21, 2026Failure to Form Staple
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846195 ↗MalfunctionSep 21, 2026Failure to Fire
It was reported that during a laparoscopic cholecystectomy procedure, the surgeon attempted to deploy clips using the device; however, no clips were loaded or deployed despite multiple firing attempts. The issue resulted in a delay to the procedure. No patient consequences.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843127 ↗MalfunctionSep 21, 2026Failure to Form Staple
It was reported that during an Unknown procedure the clips were seen coming malformed from the applicator during using the EL5ml. Was there any reported patient or user harm? No.Was there a significant delay? Yes. How long was the delay (minutes)? 20.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50838380 ↗MalfunctionSep 17, 2026Mechanical Jam
It was reported that during an unknown surgery, the clip was not fed into the jaws properly. Another device was used to complete the case. There were no adverse consequences to the patient. No further information is available.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805781 ↗MalfunctionSep 17, 2026Failure to Fire
It was reported that during a lap distal panc. EL5ML jammed. No delay or patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805746 ↗MalfunctionSep 17, 2026Failure to Fire
It was reported that during an Unknown procedure the device did not fire intra op. No harm to patient.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805658 ↗MalfunctionSep 17, 2026Mechanical Problem; Insufficient Device Problem Information
It was reported that during an Unknown procedure that item misfired and the tip looks to have separated some. There are no Injuries or Adverse event reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802106 ↗
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- LIGACLIP ER320Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE1,115 reports
- Direct Drive® Clip Applier CA090Applied Medical Resources Corporation · Clip, Implantable1 death806 reports
- LAPRA-TY XC200Ethicon Inc. · CLIP, IMPLANTABLE791 reports
- Endo Clip 176625Covidien LP · CLIP, IMPLANTABLE1 death768 reports
- LIGACLIP ER420Ethicon Endo-Surgery, LLC · CLIP, IMPLANTABLE653 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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